To accommodate several change requests submitted since version 2.0 entered in to force in September 2013, a revision of the EU eCTD Module 1 Specification has taken place and the final version is now published (EU M1 v3.0 ).
This final approved version will enter into force on 1st July 2016 and will become mandatory on 1st October 2016. After October 1st, 2016 eCTD sequences built based on EU M1 specification version 2.0 will be rejected.
Health Canada is moving towards accepting all new DMFs only in non-eCTD electronic formats or eCTD formats effective immediately. For existing DMFs some conditions apply.
FDA accepts PADER/PAER Submission in eCTD Format from June 10, 2015 onwards.
The Regulatory industry is witnessing huge transformations. Some new regulations see the light of the day as we grow in the world of automation for regulatory compliance. Intervention of information technology for submission of periodic reports in pharmacovigilance is yet another required transformation.
Q1. May I know the exact location of CRFs?
Ans. CRFs are located in in both Module 5-3-1-2 (comparative-ba-and-bioequivalence-study-report) or Module 5-3-7 (case-report-forms-and-individual-patients-listings)
As per Swissmedic the new M1 eCTD Specification (v1.3) and validation criteria (v1.3) have been edited, expanded and updated. The M1 folder structure and file naming have been modified. With a view to future eGov portal developments, a number of validation criteria have been adjusted or added in v1.3.